MAUDE Adverse Event Report: CONAIR CORP. CONAIR HEATING PAD; MASSAGING HEATING PAD

Catalog Number HP08T

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 04/20/2014

Event Type  Other  

Event Description

Consumer claims that she fell asleep while using the heating pad.The next morning she saw that she had burns in the exact locations where she positions the massaging/vibrating balls.

Manufacturer Narrative

Add'l info will be submitted upon receipt of the product from the consumer.Please note that the info booklet clearly indicates that: users are not to fall asleep while using the product; and burns can occur regardless of control setting, check skin under pad frequently.

• Brand Name: CONAIR HEATING PAD
• Type of Device: MASSAGING HEATING PAD
• Manufacturer (Section D): CONAIR CORP.; stamford CT
• Manufacturer Contact: 1 cummings point rd.; stamford, CT 06902 ; 2033519000
• MDR Report Key: 3853783
• MDR Text Key: 4660409
• Report Number: 1222304-2014-00041
• Device Sequence Number: 1
• Product Code: IRT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: HP08T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other